10 results · 20ms · Sources: EU EUDAMED, US FDA

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AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001

FDA 510(k)
FDA Class 2 ·General Hospital

POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 18, 2022

EDWARDS ESHEATH INTRODUCER SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

EDWARDS TF SHEATH UNKNOWN

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

ARCHITECT I2000SR ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 5, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 16, 2014

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·May 3, 2011

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012